JUNE 2000

WEEK ENDING JUNE 2

PRODUCT All Clini-Kits and COBE Clinical Kits containing Antiseptic Products recalled by Clinipad Corporation.
CODE All lot numbers of the following product codes manufactured by GAMBRO Healthcare, 1990 Industrial Drive, DeLand, Florida, within the last 3 years. All product codes begin with 014108 followed by: 0010C-0012C, 0014C, 0017C, 0019C-0021C, 0024C, 0025C, 0027C, 0028C, 0037C-0040C, 0043C-0045C, 0047C-0051Cl, 0053C, 0056C-0060C, 0062C, 0065C, 0066C, 0068C-0070C, 0072C, 0074C-0076C, 0079C-0083C, 0088C, 0091C-0095C, 0098C-0100C, 0102C, 0103C, 0105C, 0107C, 0109C, 0110C, 0111C, 0114C, 0115C, 0122C-0124C, 0126C, 0128C-0131C, 0133C-0135C, 0137C, 0145C, 0146C, 0150C-0153C, 0155C-0161C, 0164C, 0166C-0193C, 0201C-0203C, 0205C, 0208C, 0209C, 0211C, 0213C-0231C, 0233C-0236C, 0238C, 0240C-0250C, 0252C, 0253C, 0255C, 0257C-0259C, 0262C, 0264C, 0265C, 0268C-0271C, 0273C-0275C, 0278C-0288C, 0290C-0298C, 0300C, 0303C, 0306C, 0316C, 0318C, 0319C, 0323C, 0324C. All lot numbers of the following product codes manufactured by COBE Renal Care de Mexico S.A. de C.V., Blvd Pacifico No. 10014, Parque Industrial Pacifico, Tijuana B.C., 22480, Mexico, within the last three years. All product codes begin with 014108 followed by: 0038C, 0065C, 0134C, 0135C, 0176C, 0179C, 0190C, 0191C, 0193C, 0252C, 0253C, 0274C, 0275C, 0294C-0297C, 0299C, 0300C.
MANFACTURER Gambro Renal Products, Lakewood, Colorado.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide, The Bahamas, Canada, Mexico
QUANTITY 91,411 kits were distributed.
REASON The antiseptic products may be contaminated with bacteria.

PRODUCT Various Dialysis Kits containing antiseptic products recalled by Clinipad Corporation.
CODE
Class I: HDA Corpus - Sub, Lot #21348; HDA Corpus - Hemo, Lot # 21349; UCSF Renal - Hemo, Lot # 21333; Anderson - Hemo, Lot # 21310;
DCI Jackson, Lot # 21312 ;TEX - Hemo, Lot # 21311;TEX - Cath, Lot # 21310; Santa CLA 15, Lot # 21374;Santa CLA 16. Lot # 21375; Santa CLA 17, Lot # 21376;Western - NY, Lot # 21317; Augusta - Sub, Lot # 21342;Augusta - Hemo, Lot # 21343 ;MEDCTRHOU - Sub, Lot # 21352;
Madera, Lot # 21338; Ochner/H, Lot # 21392;Elmhurst - IN, Lot # 21344; Elmhurst - EXT, Lot # 21345;DCI - Atlanta - C, Lot # 21320; Hattiesburg, Lot # 21319;
Class II: Clinipad Iodophor PVP, Povidone Iodine pad, Code # 9153, Lot # 911636; Cliniswab Povidone-Iodine USP stick, Code # 1261,
Lot #914953.
MANFACTURER Lee Medical International, Inc., Harahan, Louisiana.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Texas, Louisiana, Mississippi, Arkansas, New York, California, South Carolina, Tennessee, Missouri, Virginia, Illinois, Georgia.
QUANTITY Approximately 27,100 kits were distributed.
REASON Class I - Products may be contaminated with bacteria.
Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.
Recall has been classified as Class I and II: Kits for which the firm was unable to identify the code and lot numbers of Clinipad products- Class I. Kits identified as containing Clinipad Code Number 9153, Lot Number 911636 and Code Number 1261, Lot Number 914953, for which the sterility could not be assured - Class II.

PRODUCT Broswlow/Hinkle Kits containing Antiseptic products recalled by Clinipad Corporation.
CODE Product Numbers: 7700BIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7730ALS, 7730IALS, 7730FLY, 7730RED, 7730BLU, 7730YEL, 7730PUR, 7730WHI, 7730MOD. Lot Numbers: (Products manufactured prior to 1998 are expired.) Year 2000 Year 1999 Year 1998
A,B,C 001-073 001-365 U, V, W 001-365 D,E,M  Example: A004 Example: 265U Example: 116M.
MANFACTURER Vital Signs, Inc., Totowa, New Jersey.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 5,016 kits were distributed.
REASON The antiseptic products may be contaminated with bacteria.

PRODUCT Various I.V. Starter and Hospital Administration Kits containing Antiseptic products recalled by Clinipad Corporation: Brown Co. I.V. Start Kit, Part #561098, 100 per case; Doctors/Mass I.V. Start Kit, Part #561696, 100 per case; Hardin Memorial Hospital, O.B. Kit, Part #561715, 8 per case; Marion Medical Center I.V. Start Kit, Part #561730, 100 per case; Toledo Hospital I.V. Start Kit, Part #561735, 50 per case; Fostoria Hospital I.V. Start Kit, Part #461751, 100 per case; Bryan Infant Kit, Part #561771, 20 per case; Promedica I.V. Start Kit, Part #561816, 100 per case; Pomerene I.V. Start Kit, Part #5610941, 100 per case; Wilson Memorial Newborn, Part #562834, 12 per case; Surgery Center I.V. Start Kit, Part #562836, 100 per case; Bixby Baby Kit, Part #562843, 12 per case; Fulton Co. IV Start Kit, Part #568053, 100 per case; Tolfree Hospital, Infant Kit, Part #568600, 10 per case; Adams County I.V. Start Kit, Part #562041, 100 per case; Jefferson Memorial Newborn Kit, Part #568662, 8 per case; and Jefferson Memorial O.B. Kit, Part #568665, 10 per case.
CODE Uncoded. All kits containing Clinipad products are subject to recall.
MANFACTURER Jones-Zylon Company, West Lafayette, Ohio.
COMPONENT MANFACTURER Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION Ohio, Missouri, Illinois, Michigan.
QUANTITY 1,500 kits were distributed.
REASON The antiseptic products may be contaminated with bacteria.

PRODUCT Capillary Dispensers. (Capillary tube or capillary blood collection tube), intended to be used by medical professionals to collect blood from a patient and to dispense the blood into a test cartridge.
CODE Catalog Number 111400, Lot 1489.
MANFACTURER Drummond Scientific, Broomall, Pennsylvania.
RECALLED BY i-STAT Corporation, East Windsor, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 1,067 units were distributed. (Each unit is a container of 50 capillary dispensers).
REASON The device is subject to elevated potassium results (a positive potassium bias of about 0.8mM) while testing capillary blood samples.

PRODUCT Vennous Catheter Kits (central, percutaneous, and single lumen) and One Arterial Kit containing PRODUCTs recalled by Clinipad Corporation.
CODE Arrow PRODUCT Numbers: AI-06210-K, AI-07155-K, AJ-13122-F, AJ-23122-F, AK-00370, AK-02903, AK-04018, AK-04020, AK-04020-C, AK-04120, AK-04122, AK-04210, AK-04212, AK-04220, AK-04225, AK-04300, AK-04301, AK-04301-LF, AK-04306, AK-04510, AK-04522, AK-04550, AK-04550-A, AK-05420-P, AK-05520-P, AK-07803-AG, AK-07903-AG, AK-08800, AK-09800, AK-09800-A, AK-09802, AK-09802-A, AK-09803, AK-09804, AK-09804-AG, AK-09805, AK-09806, AK-09806-A, AK-09807, AK-09807-A, AK-09807-AG, AK-09810, AK-09810-C, AK-09810-S, AK-09813-T, AK-09817-S, AK-09880, AK-09883-S, AK-09903-AG, AK-09903-S, AK-09903-TB, AK-09907-S, AK-09908-S, AK-11802-F, AK-12122-F, AK-12122-H, AK-12123-F, AK-12123-H, AK-12142-CF, AK-12142-F, AK-12402, AK-12702, AK-12703, AK-12703-B, AK-12802, AK-14402, AK-14502, AK-14553, AK-14703, AK-14703-A, AK-14703-H, AK-15122-F, AK-15122-H, AK-15123-F, AK15123-H, AK-15402, AK-155533, AK-15703, AK-15703-A, AK-15703-B, AK-15703-H, AK-15703-I, AK-15703-LF, AK-15703-UAB, AK-15703-V, AK-15802, AK-16402, AK-16553, AK-16702, AK-17702, AK-17702-LF, AK-22122, AK-22122-F, AK-22123, AK-22123-F, AK-22402, AK-22502, AK-22702, AK-22703, AK-22802, AK-22854, AK-24301, AK-24306, AK-24402, AK-24703, AK-24703-A, AK-24703-B, AK-24854, AK25-25122, AK-25122-F, AK-25123, AK-25123-F, AK-25402, AK-25502, AK-25553, AK-25703, AK-25703-A, AK-25703-B, AK-25703-I, AK-25703-LF, AK-25703-UAB, AK-25802, AK-25854, AK-26553, AK-26702, AK-27702, AK-35703-A, AK-35703-B, AM-09804, AM-12703, AU-22122-F, AU-23122-F, AU-25122-F, BH-09810-S, BH-12702, BH-12802, BH-22802, BP-09800, BP-09800-R, BP-09800-X, BP-09805, BT-09810, BU-15703, BU-25703, CB-04001, CH-04500, CH-09800, CH-09903-S, CK-01000, CK01410, CK-04711, CM-09800, DG-09810-AG, DG-09810-S, DH-09806, EN-00370, EU-09903-S, EU-12702, EU-12703, FS-04510, GH-22703-A, GH-24703-A, GH-25703-A, GS-05052-MW, GS-22122-F, GU-04020, HF-04020, HH-09803, JH-04210, JH-09903-S, JH-15703-B, JK-09802, JM-04120, JM-07903-AG, JM-24703, JM-25703-B, JM-25854, LC-12702, LH-04000, LH-09883-S, LI-09807, LI-09807-R, LJ-09807-S, LO-05801, LV-15703-A, ME-04018, ME-04020, MG-09903-S, MG-25703-A, MH-090800, MH-09810-VKS, MH-22703, MK-02031-TW, MK-02041-T, MK-02051-T, MM-09803, MM-09817-S, MM-09883, MM-24703, MM-24854, MW-09880, MS-02031-TW, MS-020401-T, MS-02051-T, MZ-09883-S, NA-32703, NE-09805, NH-09803-B, NH-12703, NL-09903-S, NF-09880, NR-07803-AG, NR-07903-AG, NR-09810-S, NR-09903-S, NR-12703, NR-22703, NR-22802-B, NR-25854, NS-09803, OS-04510, PB-04000, PB-04001, PC-09903-S, PC-14703-AC, PG-09810-S, PH-09805, PH-09806, PK-01351, PK-01351-TW, PK-01351-W, PK-01451, PK-01451-S, PK-01451-T, PK-01451-TW, PK-01451-W, PK-01451-WS, PK-01452, PK-01452-W, PK-01552, PK-01552-S, PK-01552-W, PK-01552-WS, PM-09903-K, PR-05041, PR-05041-LW, PR-05041-T, PR-05052, PR-05052-LW, PR-05052-MW, PR-07051-T, PR-07051-TLW, PR-07051-TMW, PS-01651, PS-01652, PS-01671, PS-09810-S, RH-09801, RH-22703, RH-25703, RP-09883-S, RP-09903-S, RR-22854, RV-15703, SB-09810-S, SB-09903-S, SE-09810-SSH-04306, SH-24306, SH-25703-A, SJ-07802, SJ-09200, SJ-09805, SJ-12702, SK-04812, SL-04710, SL-09807, SL-22802, SM-01410, SM-05503, SM-09802, SM-14703, SM-15703, SR-09907, SU-04300, SU-09903-S, SV-09804, SV-12703, TA-09880, UA-09800, UC-09880-S, UP-04710, UP-09806, UP-15703, UT-09880, VA-05502, VA-09802, VA-25703-B, WB-09810-S, WB-12702, WC-09804, WH-09807, WH-09883-S, WH-14703, WJ-01000, YN-09903-S, YN-15703 & YN-15703-S.
MANFACTURER Arrow Intl., Inc., Reading, Pennsylvania.
COMPONENT MANFACTURER Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Kits contain Clinipad products (alcohol prep pads, bezoin tinet swabssticks, povidone iodine prep pad, povidone iodine ointment, and alcohol swabsticks) labeled as sterile for which Clinipad is unable to assure their sterility

PRODUCT Power Wheelchairs: a) Power Tiger; b) P7E with duel battery box upgrade only, c) 9M; d)Excel; e) PMC; d) Ranger II.
CODE Serial Numbers 93D through 99C.
MANFACTURER Invacare Corporation, Elyria, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 77,408 units were distributed.
REASON Wheelchairs may catch fire due to improper wiring harnes configuration.

PRODUCT Blood Collection Needle with Sheath, 21 GA. x 1" Needle, single use only, Sterile: Unless package is opened or damaged.
CODE REORDER No. N-621. All lots of product packed in green plastic pouches.
MANFACTURER North American Medical Products, Inc., Albany, New York.
DISTRIBUTION New York, California, New Jersey, Massachusetts, Canada.
QUANTITY 19,200 units were distributed.
REASON Package integrity - lack of assurance of sterility.

PRODUCT Various procedure trays containing including the following:
Central Line Dressing, Midline/PICC Line Support, Subclavian On/Off, Dressing Change, Nerve Block, VAD Access, General Purpose Instrument, I.V. Start, Suture Removal, Ventriculostomy, Wound Care, Urethral/Foley Catheter, Catheter Care, under the Medcare and 14 private labels: Medical Marketing, Catalog #DK7-7178; Capital Medical Inc., Catalog #CMI-2001; UHS?HCI St. Louis, Catalog #DF8-8047; Owens and Minor (Touro Infirmary-label), Catalog #DP2-2161; Rockwell Medical, Catalog #RW-1020, 2011, 2100; Modern HomeCare, Catalog #DK7-0312; Patients Choice (Hospice or SpectraCare label), Catalog # DK7-7119 & IF9-9099; American Homepatient, Catalog #DK7-0444; OptionCare (Corporate), Catalog #DN7-7099; Children's Hospital Medical Center, Catalog #DP2-2052; Medtronic PS Medical, Catalog #46155.
CODE The recalled trays include approximately 68 different catalog numbers and approximately 120 different lot numbers. (NOTE: If necessarya complete of catalog numbers and lot numbers can be obtained from the New England District Office Recall Coordinator).
MANFACTURER Medcare Medical Group, Inc., East Swanzey, New Hampshire.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 7,504 cases, containing a total of 244,022 units.
REASON Procedure kits contain recalled Clinipad antiseptic products.

PRODUCT Castle Series 200 Steam Sterilizer (Powerclave), intended for sterilizing medical devices for use in hospitals and health care facilities: a)Castle Model 222: Gravity Steam Sterilizer, Double Door;
b) Castle Model 233: Vacuum Steam Sterilizer, Single Door. Safety Alert #N-015/016-0.
CODE Serial #s range from 97A58318 thru 99M60565. The first 3 characters represent the year and month. (A=January, etc.) The last five numbers are consistent with pressure vessel identification. NOTE: There are sterilizers within this serial number range that are NOT affected by this field correction. However, those sterilizers have different model numbers than those subject to this safety alert.
MANFACTURER Getinge/Castle, Inc., Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 286 sterilizers were distributed.
REASON Sterilizer door opened during sterilization cycle due to damaged door hook.

WEEK ENDING JUNE 9

PRODUCT Human Wrist Restraints, used in a hospital setting to restrain the limbs of patients that may be a harm to themselves or attendants: a) Connected Wrist Restraint, Catalog Numbers 2204 and 2205
b) Locking Synthetic Strap, Catalog Numbers 2212 and 2213.
CODE Serial Numbers: Julian Date 00006-000067 and Julian Date 00006-000067.
MANUFACTURER J.T. Posey Company, Arcadia, California.
DISTRIBUTION Nationwide, Puerto Rico, France, The Netherlands.
QUANTITY a) 152 units; b) 4 units were distributed.
REASON The devices were manufactured with materials that did not meet specifications.

PRODUCT Cordis French, Mutipacs, Primopacs, Propacs and other modified Angio Catheters and certain Endovascular 6 Fr Supertorque models: a) 6 Fr Supertorque; b) 6 French Supertorque Plus; c) 7 French Supertorque Plus; d) 6 French Plus TL Diagnostic Catheters; e) Multipac Kit (with preceding catheters); f) Propac Kit (with preceding catheters); g) Primopac Kit(with preceding catheters); h) Modified Special Product (with preceding catheters).
CODE All unexpired codes of the listed Cordis products as listed above which include Model Numbers manufactured from 1997 to present are under recall. Also 142 additional Endovascular catheters. In this case ONLY the listed model AND LOT NUMBERS are under recall because these lots contain recalled catheters. Endovascular 6Fr Supertorques:Standard Catalog #'s, Lot #'s affected by recall
Item                 Lot             Item             Lot
455611T     S0199292     455611T     S0799745
455611T     R098299        455613E     R0799884
455613S     R0999428      455660D     W1198082
455662       S1298554       455665       R0299589
Item                             Lot       Units         Item                             Lot                 Units
TS63810000HS     E0198004     5         ST63810000SIM2         E0198025         20
520000 08876         E0198045     5         ST63810002SIM2         E0198054         60
520000 13228         E0199002     5         520000 09327                 E0199012         5
520000 09327         E0199020     5         ST63810000SIM3         E0199021         10
520000 13228         E0199027     10         MODC18065               E0200005         10
ST63810002SIM2  E0298051     50         ST63810002SIM2       E0299019        15
MODC18065           E0300001     10         ST63810000SIM2       E0398031       20
520000 08876           E0398040       5         520000 13228               E0398041          5
520000 13228            E0398051       5        TS63810000HS            E0399002          20
ST63810000SIM3    E0399003      10        ST63810002SIM2       E0399009          20
ST63810000SIM3    E0498011       15       ST63810000SIM2        E0498020          5
ST63810002SIM2    E0499004       30       TS63810000HS             E0499017        15
520000 13764            E0597010         5       ST63810000SIM4          E0597015       30
ST63810000SIM3     E0597022      15       ST63810000SIM2          E0597061       10
520000 08876             E0597076         5      ST63810000SIM4          E0598041         5
520000 08876             E0697037         5       TS63810000HS              E0698013        5
520000 13764            E0698024         10      520000 13764                 E0698028        5
ST63810000SIM2     E0698041        10       ST63810000SIM3         E0698061        5
MODC13764             E0699008          5       MODC18065                E0699020        10
ST63810000SIM2     E0797056         10      TS63810000HS             E0797109        20
520000 13228             E0798014        5          ST63810000SIM2        E0798026         5
ST63810000SIM2     E0798031        45        520000 09327                 E0897034        15
TS63810000HS          E0897074          5         520000 13764               E0898008          5
ST63810002SIM2     E0898015         30        520000 13228                E0898034          5
TS63810000HS         E0997007           5         TS63810000HS             E0997010         5
520000 13764            E0997063           25        TS63810000HS             E0997064         10
520000 13228            E0998016             5        TS63810000HS            E0998017          10
520000 13764            E0998026             5         520000 08876               E0998032            5
ST63810000SIM1    E0998033             5         TS63810000HS            E0998034          10
520000 13764            E0998038           10         520000 09327               E1097005            5
ST63810000SIM3     E1097016          20          520000 09189               E1097035          20
TS63810000HS         E1097055             5         520000 13764                E1098005            5
ST63810000SIM3     E1098045           20         MODC18065                 E1099003         10
MODC18065              E1099016          10          TS63810000HS             E1197028         25
TS63810000HS          E1198021           15          TS63810000HS            E1198025          10
520000 09189             E1198030            10          520000 09189               E1198035          10
520000 08876             E1198042              5          TS63810000HS           E1198043             5
ST63810000SIM2    E1297026              15          ST63810000SIM3       E1297036           10
520000 09327            E1298001               5           MODC18065               E1299004             10
MODC13052            K0100077               5           TS73808000C2            K0199004             5
TS73806500STR      K0199096               5            MODC08876               K0200197            5
MODC17857            K0200274              10          MODC17857                K0200386             5
ST63812500SIM1    K0299238               5           ST63812500H1              K0299239            5
TS73806500STR      K0299263               5          520000 17428                 K0299266            40
TS73806500STR      K0398145              10         TS73808000C2              K0398257              5
520000 17428           K0398312               10          TS73808000C2              K0398347             5
520000 17429           K0398358                10          520000 17417                K0498054             5
TS73808000C2         K0498238                   5        TS73808000C2              K0498239             5
TS73808000C2         K0499006               20           ST63812500SIM1        K0499021             5
TS73808000C2        K0598040                  5           MODC13052                K0599104             5
MODC17924            K0599186                5            MODC13052               K0599358             15
MODC12147           K0599482                10           ST63806502C3            K0698115               5
MODC12147          K0699112                 10           MODC18045                K0699128              5
MODC18076          K0699340                   5            MODC17857               K0699415             5
MODC17857          K0798249                25            MODC17857               K0799089            15
TS73808000C2      K0898159                  5             TS73806500SIM2       K0898164            10
ST63806506STR   K0898195                 10           MODC17848                K0899310             20
MODC17428         K0899351                  5            TS73808000C2             K0998213               5
ST63806502C2      K0998257                  5            MODC17848                K0999152              20
MODC13052         K0999232                25            MODC17857                K0999422               15
TS63808000SIM2  K1097050               10             ST63806506STR          K1098116              10
ST63806502C2      K1098117                  5              520000 17428               K1098134                 5
TS73808000C2       K1098262                 5              MODC18328               K1099245                  5
MODC08101         K1099430                45              TS73808000C2            K1198268                  5
MODC18390         K1199326                  5                MODC13052              K1199338               15
ST63810000VER   K1298168                  5                MODC08101              K1299065                5
MODC08101 K1299074 5.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 6,573 lots and 6,451,609 catheter units were distributed since 1997.
REASON The catheters may have unexpected fibers in inner lumen which may loosen into the blood.

PRODUCT CML, Inc. Kits and Trays for particular medical procedures. Most of the kits and trays are custom products, manufactured differently for individual customers:
CVC Dressing Change Kits, product number 02-138
CVC Dressing Change Trays, product numbers 1918, 02-004, 02-005, 02-008, 02-012, 02-014, 02-020, 02-021, 02-023, 02-026, 02-028, 02-029, 02-030, 02-034, 02-036, 02-039, 02-052, 02-105, 02-106, 02-122, 02-123, 02-130, 02-131, 02-133, 02-135, 02-140, 02-141, 02-143, 02-146, 02-148, 02-150, 02-152, 02-153, 02-154, 02-156, 02-158, 02-161, 02-162, 02-164, 02-165, 02-167, 02-168, 02-175, 02-176, 02-177, 02-178, 02-179, 02-185, 02-187, 02-402, 02-403, 02-423, 02-42B, 02-445, 02-610, 02-008A, 02-026A, 02-402B; 2006, 2025, 5050, 5062, 5068, 6010HP, 6010-2, 6011, 6012-1, 6013, 6016, 6017, 6018, 6019, 6021, 6022, 6028, 6029, 6030-1, 6033, 6036, 6037, 6038, 6042, 6046, 6048, 6051, 6052, 6053, 6059, 6063, 6066, 6067, 6071, 6072, 6076, 6077
Central Line Dressing Change Kits, product numbers 02-157, 02-159
PICC/Central Line Dressing Change Kit, product #02-183
Central Line Change Trays, product numbers 02-121, 02-145, 02-182, 4550
RJDT 2820 Central Line Dressing Change Tray
TPN Tray, product number 9002
TPN/CVP Dressing Change Kits, product nos. 02-001, 02-003
CVP/TPN Dressing Change Trays, product #6027
CVC/TPN Dressing Change Tray, product number 02-124
IMS CVC Dressing Change Tray, product number 02-169
Wausau VNA CVC Dressing Change Tray, product number 02-181
BMR-160 CVP Dressing Change Tray
HCA 02-402 CVC Dressing Change Tray
Dressing Change Kits, product number 01-160, 02-192, 02-198, 02-457, 2150
Dressing Change Kit with Island Dress, product #02-190
Dressing Change Trays, product numbers 01-162, 01-163, 02-032, 02-033, 02-134, 02-163, 02-180, 02-88, 2011, 2190DC, A371-83, 6065, 6079
Dress Change Hard Tray, product number 02-196
CD Dressing Change Kit, product number 2023
Amicare Dressing Change Tray, product number 5000
CD02121 Dressing Change Tray, product number D2133
RJ2133 Dressing Change Tray
SJH1000 Dressing Change Kit
St. Joseph's Dressing Change Tray, product number 02-184
VAD Access Kits, 02-050, 02-051, 02-053, 02-058, 02-116, 7020
VAD Insertion Trays, product numbers 02-114
Catheter Insertion Trays, product numbers 02-101, 02-102, 02-103, 02-112, 02-117, 6043
Catheter Insertion Kit, product number 02-115
PICC Tray, product number 6026
PICC Line Tray, product number 6020, 7022
PICC Dressing Tray, product number 60201
PICC Dressing Change Kits, product number 02-137
PICC Dressing Change Trays, product number 02-108, 02-109, 02-111, and 02-136
BMR145-1 PICC Line Tray
RJDT3555 PICC Line Tray, Latex-Free
Midline Kit, product number 02-274
Midline Trays, product numbers 02-221 and 02-270
Midline Insertion Trays, product numbers 02-271, 02-279
PICC Kit, product numbers 2062, 2064
PICC Midline Tray, product number 02-222
Midline Catheter Prep Tray, product number 7012
Midline Catheter Support Tray, product number 02-151
Midline Catheter Care Kit, product number 02-273
Peritoneal Kit, product number 02-189
Port Access Trays, product number 02-194
TPN Dressing Change Kits, product numbers 02-126, 02-191
TPN Dressing Change Trays, product numbers 02-128, 02-193
CVC/TPN Dressing Tray with Drape, product number 02-02T
CVC/TPN Dressing Change Tray, product number 02-124
C.V.P. Dressing Change Tray, product number D2133
CHM2500 Urethral Catheter Tray
CHM2500A Urethral Catheter Tray
Urethral Catheterization Tray, product number 3022015
CHM2000 Foley Insertion Kit
IV Start Kits, product numbers 01-147, 5056, 6008, 6080
Chow Change Tray, product number 02-425
Chow Dressing Change Tray, product number 02-025, 02-031, 02-427
Chow Dressing Change Kits, product numbers 1910, 02-431
RJDT2825 Chow Dressing Change Tray
IU Medium Dressing Change Trays, product numbers 02-037, 6068
Home Care Kit, product number 02-055
Home Care Kit with B-D Syringe, product number 02-054
SJH3000 Sub Q Port Kit
IV Dressing Change Kits, product numbers 5054, 6024
IV Dressing Change Tray, product number 02-110
Children Dressing Change Tray, product number 02-127
Option Care D.C. Kit, product number 02-197
Dialysis Dressing Change Tray, product number 02-223
Wound Care Tray, product number 2270
Deridement Tray, product number A37182
Oncology Tray, product number 6075
A1796L-1 Lesion Removal Pack
BB-27 Groshong Prep Kit.
CODE All lots of the products are to be checked for the Clinipad swabsticks.
MANUFACTURER Continental Medical Laboratories, Inc., Waterford, Wisconsin.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hills, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,000 kits.
REASON Kits contain Clinipad products labeled as sterile for which Clilnipad is unable to assure the sterility.

PRODUCT Vas-Cath Hemodialysis Catheters (Opti-Flow, Soft-Cell, Flexxicon, Flexxicon II, Trialysis, Vaccess, Niagara, and Hemofiltration.
CODE OPTI-FLOW PERMANENT DIALYSIS CATHETERS
Product Code Lot Number
5631190 - - - - 22KJ1419, 22LJX030
5631230 - - - - 22KJ1418, 22LJX016
5631690 - - - - 22BK1820, 22KJ1427, 22LJX033, 22LJX045
5631692 - - - - 22LJM011
5631730 - - - - 82EJ0111, 82GJ0007
5632190 - - - - 22KJ1426
5632192 - - - - 22KJ1407
5632230 - - - - 22LJM010
5632232 - - - - 22LJM012
5633190 - - - - 22KJ1425, 22LJX031, 82BJ0074, 82CJ0114, 82KJ0002
5633192 - - - - 82BJ0072, 82CJ0117
5633230 - - - - 22KJ1423, 22LJX017, 82CJ0116
5633232 - - - - 82BJ0073, 82JJ0009
5633690 - - - - 22KJ1431, 22LJM006, 82CJ0053, 82DJ0149, 82GJ0002
5633690 - - - - 82KJ0003
5633692 - - - - 22DJ0111, 22HJM707, 22HJM708, 22JJO758, 22KJM002, 82DJ0035, 82DJ0150, 82DJ0151, 82GJ0003, 82IJ0004, 82IJ0005, 82IJ0031, 82IJ0033, 82JJ0005
5633730 - - - - 22BK1823, 22IJM726, 22KJ1428, 22LJM007, 82BJ0075, 82EJ0112, 82GJ0006, 82HJ0007, 82JJ0008.
5633732 - - - - 22IJM734, 22LJM009, 22LJM016, 22LJM017, 82DJ0037, 82EJ0113, 82GJ0004, 82GJ0005.
5633732 - - - - 82IJ0006, 82IJ0007, 82JJ0007, 82JJ0008.
5634190 - - - - 22BK1822, 22KJ1430, 82DJ0034, 82EJ0109, 82EJ0110, 82FJ0004, 82GJ0008, 82GJ0009, 82HJ0011, 82KJ0001.
5634192 - - - - 22AKM021, 22AKM022, 22AKM024, 22BK1833, 22BK1834, 22BK1835, 22LJM005, 82CJ0054, 82DJ0036, 82EJ0043, 82EJ0044, 82HJ0002, 82HJ0003, 82IJ0001, 82IJ0002, 82IJ0003, 82JJ0001, 82JJ0002, 82JJ0003.
5634230 - - - - 82FJ0002, 82HJ0004, 82HJ0008.
5634232 - - - - 82CJ0055, 82FJ0003, 82HJ0005, 82HJ0006, 82HJ0009, 82HJ0010, 82IJ0008, 82IJ0030, 82JJ0033.
5635192 - - - - 36FJ0156.
5635232 - - - - 36BJ0130, 36DJ0208, 36DJ0212.
5635692 - - - - 36AK0036, 36BJ0131, 36CJ0184, 36DJ0206.
5635732 - - - - 36BJ0132, 36DJ0232, 36LJ0048.
5636192 - - - - 36AK0035, 36DJ0207, 82EJ0044.
5636232 - - - - 36BJ0130, 36DJ0208, 36LJ0066.
NIAGARA TEMPORARY DIALYSIS CATHETERS
5577121 - - - - 22AK1472, 22IJ0742, 22JJ0773, 82CJ0003, 82CJ0004.
5577202 - - - - 22BK1851, 22KJ1401, 82CJ0169, 82CJ0170.
5577224 - - - - 22AK1445, 22FJ0378, 22IJ0744, 22LJ1434, 22LJX044, 82CJ0008, 82CJ0168.
5678122 - - - - 22BK1825, 82CJ0002.
5678155 - - - - 22FJ0404, 22IJ0746, 22KJ0787, 22KJ0794, 82CJ0005, 82CJ0010, 82CJ0173.
5678202 - - - - 82CJ0006.
5591150 - - - - 22AK1441, 22FJ0400, 22IJ0740, 22JJ0774, 82CJ0167.
5591200 - - - - 22AK1477, 22BK1853, 22CJ0085, 22CJ0101, 22FJ0375, 22HJ0704, 22JJ0760, 22KJ0795, 22KJ1400, 22LJX026.
5591240 - - - - 22IJ0737.
5592120 - - - - 22BK2108, 22DJ0147.
5592150 - - - - 22AK1443, 22BK1847, 22CJ0080, 22DJ0157, 22FJ0401, 22HJ0702, 22IJ0745, 22JJ0759, 22JJ0776, 22LJX022.
5592200 - - - - 22AK1444, 22AK1484, 22AK1491, 22CJ0081, 22CJ0100, 22GJ0452, 22KJ0789, 22KJ0790, 82CJ0171.
5593150 - - - - 22AK1442, 22AK1809, 22BK1846, 22DJ0162, 22EJ0327, 22GJ0453, 22IJ0741, 22JJ0754, 22KJ1402, 22LJX004.
5593200 - - - - 22AK1808, 22BK1852, 22DJ0163, 22EJ0328, 22FJ0409, 22JJ0749, 22LJX027.
5593240 - - - - 22AK1812, 22DJ0161, 22FJ0377, 22IJ0738, 22KJ1414, 22LJ1435, 22LJX043.
5594120 - - - - 22AK1813, 22DJ0165, 22FJ0402, 22KJ1403, 22KJ1411.
5594150 - - - - 22BK1849, 22BK1850, 22FJ0403, 22IJ0747, 22JJ0777, 22KJ1408, 22LJX001, 82BJ0056.
5594200 - - - - 22AK1492, 22AK1814, 22FJ0405, 22GJ0454, 22KJ0791, 22LJX036.
5595150 - - - - 36AK0033, 36BJ0125, 36CJ0158, 36DJ0210, 36FJ0152, 36GJ0112, 36HJ0179, 36KJ0011, 36LJ0008.
5595200 - - - - 36AK0051, 36BJ0126, 36CJ0161, 36FJ0153, 36GJ0115, 36HJ0182, 36HJ0183, 36JJ0067, 36KJ0012, 36LJ0010, 36LJ0065.
5595240 - - - - 36BJ0127, 36CJ0159, 36GJ0113, 36HJ0180, 36KJ0014.
5596120 - - - - 36CJ0163, 36DJ0209, 36FJ0155, 36GJ0117, 36HJ0184, 36KJ0010, 36LJ0007.
5596150 - - - - 36AK0032, 36AK0050, 36BJ0128, 36CJ0160, 36DJ0210, 36GJ0114, 36HJ0181, 36LJ0009.
5596200 - - - - 36AK0034, 36BJ0129, 36CJ0162, 36DJ0211, 36FJ0154, 36GJ0116, 36HJ0183, 36KJ0013, 36LJ0011.
FLEXXICON II TEMPORARY DIALYSIS CATHETERS
5521150 - - - - 22AK1457, 22BJ0046, 22BK1827, 22BK2113, 22CJ0099, 22EJ0171, 22FJ0367, 22GJ0425, 22KJ1405.
5521200 - - - - 22AK1436, 22BJ0047, 22BK2103, 22EJ0172, 22EJ0348.
5521240 - - - - 22BJ0048, 22DJ0117, 22EJ0173, 22EJ0349.
5522120 - - - - 22CJ0055.
5522150 - - - - 22AK1454, 22BJ0028, 22BK1838, 22CJ0056, 22EJ0169, 22EJ0174, 22GJ0423, 22LJX023.
5522200 - - - - 22CJ0057, 22EJ0170, 22FJ0368, 22GJ0424, 22IJ0715, 22IJ0722, 22IJ0723.
5522650 - - - - 22BK2100.
5522700 - - - - 22DJ0129.
5523150 - - - - 22AK1468, 22BK1841, 22BK2114, 22CJ0069, 22CJ0098, 22EJ0179, 22FJ0384, 22GJ0432.
5523200 - - - - 22AK1437, 22BK2104, 22CJ0097, 22EJ0181, 22EJ0356.
5523240 - - - - 22CJ0068, 22EJ0183.
5524120 - - - - 22CJ0089, 22EJ0176.
5524150 - - - - 22BK1839, 22CJ0090, 22DJ0132.
5524200 - - - - 22DJ0131, 22LJX006, 82CJ0073.
5524620 - - - - 22EJ0175, 82CJ0056.
5524650 - - - - 22BK2101, 22BK2115, 22CJ0067, 22EJ0177, 22GJ0429.
5524700 - - - - 22BK1836, 22DJ0130, 22GJ0430, 82CJ0072.
5525150 - - - - 22DJ0136, 22DJ0137, 22EJ0187, 22FJ0410, 22LJX020.
5525200 - - - - 22DJ0138, 22DJ0139, 22EJ0311, 22EJ0313, 22GJ0436.
5525240 - - - - 22DJ0140, 22EJ0188, 22FJ0385, 82BJ0080.
5526120 - - - - 22DJ0141, 22EJ0186, 22GJ0434.
5526150 - - - - 22DJ0156, 22FJ0397, 82BJ0077.
5526200 - - - - 22DJ0155, 22FJ0398, 22GJ0435, 22LJX014, 82CJ0075.
5526650 - - - - 22DJ0148, 82BJ0076.
5526700 - - - - 82CJ0074.
5577105 - - - - 22BK2117, 22FJ0394.
5577115 - - - - 22BK1840, 22CJ0087, 22FJ0370, 82BJ0064.
5577135 - - - - 22CJ0058, 22EJ0178, 22FJ0396, 22GJ0431.
5577215 - - - - 22AK1458, 22CJ0063, 22EJ0180, 22FJ0372, 22KJ1406.
5577220 - - - - 22AK1439, 22BK2105, 22CJ0062, 22DJ0119, 22EJ0182, 22EJ0357, 22GJ0433.
5577324 - - - - 22AK1446, 22AK1453, 22AK1469, 22CJ0061, 22DJ0120, 22EJ0184, 22FJ0371, 22JJ0756, 22KJ0780, 22LJX007.
SOFT CELL PERMANENT DIALYSIS CATHETERS
5500100 - - - - 22CJ0070, 22KJ0796, 22LJX032.
5531120 - - - - 22BJ0008.
5531190 - - - - 22DJ0102.
5531230 - - - - 22BJ0010, 22FJ0412, 22IJ0711.
5531620 - - - - 22BJ0007, 22BK1815, 22FJ0379.
5531690 - - - - 22GJ0470.
5531730 - - - - 22AK1478, 22AK1496, 22CJ0083.
5532120 - - - - 22BJ0004.
5532190 - - - - 22DJ0103, 22EJ0196, 22FJ0366.
5532230 - - - - 22BJ0054
5533120 - - - - 22DJ0128, 22EJ0198.
5533190 - - - - 22BK1816, 22DJ0108, 22EJ0301, 22FJ0382, 22KJ0798.
5533230 - - - - 22AK1497, 22CJ0073, 22DJ0116, 22FJ0413, 22LJX041.
5533620 - - - - 22DJ0127.
5533690 - - - - 22AK1450, 22DJ0107, 22EJ0300, 22FJ0381, 22GJ0471.
5533730 - - - - 22DJ0110, 22FJ0383.
5534120 - - - - 22DJ0105, 22EJ0199, 22GJ0468.
5534190 - - - - 22AK1449, 22AK1479, 22BK1817, 22CJ0072, 22DJ0109, 22FJ0407.
5534230 - - - - 22CJ0071, 22DJ0111, 22FJ0414, 22LJX024, 82JJ0005.
5536190 - - - - 22DJ0145.
VACCESS SINGLE-LUMEN DIALYSIS CATHETERS
5541150 - - - - 22BJ0005, 22BK1832, 22EJ0307, 22EJ0345, 22GJ0426.
5541200 - - - - 22BJ0006, 22EJ0308, 22EJ0346, 82DJ0157.
5541650 - - - - 22EJ0309.
5541700 - - - - 22EJ0310, 22EJ0347, 82DJ0154, 82ADJ0155, 82DJ0156.
5542150 - - - - 22EJ0302, 22EJ0314, 22EJ0341.
5542240 - - - - 22CJ0082, 22DJ0123, 22EJ0304, 22EJ0343.
5542650 - - - - 22EJ0303, 22EJ0342, 22IJ0712, 22IJ0713, 22IJ0714.
5542700 - - - - 22AK1447, 22DJ0113, 22EJ0305.
5543150 - - - - 22DJ0152, 22EJ0320.
5543200 - - - - 22EJ0321.
5543650 - - - - 22DJ0114, 22EJ0322, 22EJ0354.
5543700 - - - - 22DJ0115, 22EJ0323, 82DJ0153.
5544150 - - - - 82BJ0081.
5544200 - - - - 22DJ0126, 22EJ0317, 22EJ0352.
5544650 - - - - 22DJ0125, 22EJ0315.
5544700 - - - - 22EJ0353.
5577250 - - - - 22GJ0442.
5577265 - - - - 22DJ0149.
5577270 - - - - 22DJ0158, 82DJ0152.
5577275 - - - - 22CJ0084.
HEMOFILTRATION CATHETERS
5573110 - - - - 22KJ1095, 82BJ0022, 82CJ0059, 82DJ0039.
MANUFACTURER Bard Access Systems, Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 175,034 units were distributed.
REASON Cracked luer connectors which could cause air embolisms or blood loss.

PRODUCT Cordis Savvy PTA Balloon Catheters:
Model: 435200L, 435200S, 435202L, 435202S, 435202T, 435202X, 435203L, 435203S, 435203X, 435204L, 435204S, 435204X, 435206L, 435206S, 435250L, 435250S, 435252L, 435252S, 435252X, 435253L, 435253S, 435253X, 435254L, 435254S, 435254X, 435256L, 435256S, 435300L, 435300S,
435302L, 435302S, 435302X, 435303L, 435303S, 435303X, 435304L, 435304S, 435304X, 435306L, 435306S, 435350L, 435350S, 435352L, 435352S, 435352X, 435353L, 435353S, 435353X, 435354L, 435354S, 435354X, 435356L, 435356S, 435499L, 435400S, 435402L, 435402S, 435402X, 435403L,
435403S, 435403X, 435404L, 435404S, 435404X, 435406L, 435406S, 435450L, 435450S, 435450Y, 435452L, 43542S, 435452Y, 435454L, 435454S, 435454Y, 435456L, 435456S, 435456Y, 435500L, 435500S, 435500Y, 435502L, 435502S, 435502Y, 435503L, 435503S, 435503Y, 435504L, 435504S,
435504Y, 435506L, 435506S, 435506Y, 435550L, 435550S, 435550Y, 435552L, 435552S, 435552Y, 435553L, 435553S, 435553Y, 435554L, 435554S, 435554Y, 435556L, 435556S, 435556Y, 435699L, 435600S, 435600X, 435600Y, 435602L, 435602S, 435602Y, 435603L, 435603S, 435603Y, 435604L,
435604S, 435604Y, 435606L, 435606S, 435606X, 435606Y.
CODE A total of 790 lots are involved which represents all unexpired product produced from May 1998 to present.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 790 lots or 11,550 units.
REASON Hub leakage during flushing of catheters because of cracks.

PRODUCT Exacta External Drainage and Monitoring System, used for externally draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain and monitoring intracranial pressure due to head trauma.
CODE Catalog No. 46700, Lot Nos. R5651 through R5657, R8515, R9255, R9581, R9938, T0419, T1262, T1974, T2528, T2645, T3237, T3515, T4771, and T5140.
MANUFACTURER Medtronic PS Medical, Goleta, California.
DISTRIBUTION Nationwide and international.
QUANTITY 1,895 units were distributed.
REASON The device's sterility may be compromised due to loss of package integrity and which may possibly allow bacteria to enter the patient.

PRODUCT Pacesetter Trilogy Pulse Generator, indicted for the treatment of bradycardia:
a) Trilogy SR 2250 Pulse Generator; b) Trilogy SR+ 2260 Pulse Generator; c) Trilogy SR+ 2264 Pulse Generator; d) Trilogy DC 2308 Pulse Generator; e) Trilogy DC+ 2318 Pulse Generator; f) Trilogy DR 2350 Pulse Generator; g) Trilogy DR+ 2360 Pulse Generator; h) Trilogy DR+ 2364 Pulse Generator.
CODE Serial Numbers:
53184-53232 ;53433-53478 ;53983-54032 ;54673-54722 ;55526-55572; 55873-55971; 56273-56422 ;58113-58205; 58966-59014 ;
59316-59372 ;59778-59822 ;61075-61122; 61433-61532 ;61633-61725; 62133-62182 ;63233-63281; 66851-66959; 66970-66994.
MANUFACTURER St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 144,000 generators.
REASON An anomaly with the microprocessor integrated circuit was detected. The anomaly behavior includes: Interrogation/programming difficulties, including the presence of dashes (---) on the programmer screen for some parameter values after interrogation; Unexpected rate variations; Abnormally high battery current drain; Mode change

PRODUCT Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers 006-04100-00, 006-04100-01, 006-04100-00S, 006-04100-01S, and 006-04100-02.
CODE All units shipped prior to March 30, 2000.
MANUFACTURER Merge Technologies, Inc., West Allis, Wisconsin.
DISTRIBUTION California, Connecticut, Indiana, Illinois, Kansas, Minnesota, Missouri, Nebraska, Ohio, Oregon, Texas, Brazil, Denmark, The Netherlands, Sweden.
QUANTITY 168 units were distributed.
REASON Warning label which limits product use was omitted from the cable of the video units.

PRODUCT U-100 Insulin Single Use Syringes, 29 G X 1/2 inch and U-100 Insulin Single Use Syringes, 28 G X 1/2 inch.
CODE Lot Number 990427 for the 28 gauge X 1 cc product and Lot Number 990426 for the 29 gauge X 1 cc product
MANUFACTURER Medicore, Inc., Hialeah, Florida.
DISTRIBUTION New Jersey and Florida.
QUANTITY 100 cases (100 syringes per case) were distributed.
REASON Mislabeled volume on outer shelf cartons, device package is correct.

PRODUCT Alycon Reagent Probe LN 05D44-01.
CODE None.
MANUFACTURER Abbott Laboratories, Inc., Diagnostics Division, Irving, Texas.
DISTRIBUTION Nationwide, Japan, Puerto Rico.
QUANTITY 78 units were distributed.
REASON The box labeled as containing a Reagent Probe actually contained an ISE probe.

WEEK ENDING JUNE 16

PRODUCT a) Bennett X-Ray Contour Mammography Systems, Model numbers: M-CTR-2000, M-CTR-2000-3P, M-CTR-P, M-CTR-3P; b) Profile Mammography Systems, Model numbers: M-PRO-2000, M-PRO2000-3P, M-PRO, diagnostic X-ray devices used in mammography.
CODE None
MANUFACTURER Bennett X-ray Corporation, Danbury, Connecticut.
RECALLED BY Trex Medical Corporation, Danbury, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 607 units were distributed.
REASON The units are noncompliant with 21 CFR 1020.31(m) in that the transmission limit 5-cm beyond the plane of the image receptor support device exceeds 0.1 mR per exposure. This can result in the patient receiving unnecessary exposure.

PRODUCT Model Gallium Elite and Midi Laser System, for use in pain therapy for animals.
CODE None.
MANUFACTURER Sim-Med Ltd., United Kingdom.
DISTRIBUTION Florida, Alaska.
QUANTITY 3 units of each model were distributed.
REASON The device failed to comply with 21 CFR 1010.2, 1010.3, and 1040.10 (f) (6) (i) in that the products lack required certification and identification and compliance with the beam attenuator requirement.

PRODUCT Vacutainer Brand Evacuated Blood Container, partial draw sodium citrate tubes.
CODE Catalog Numbers: 369711, 369700, 367712, 367703, 367715, 366416, 369705, 367707, 366419.
MANUFACTURER Becton Dickinson & Co., Broken Bow, Nebraska.
RECALLED BY Becton Dickinson & Company, Franklin Lakes, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Not applicable.
REASON Increased platelet activation in partial draw tubes.

PRODUCT Procedure Tray, Fixture Installation, Catalog #25369, dental handpiece and accessories.
CODE Lot numbers: 802899, 803109, 803183, 803237, and 803711.
MANUFACTURER Nobel BioCare AB, Gothenburg, Sweden.
RECALLED BY Nobel BioCare USA Inc., Yorba Linda, California.
DISTRIBUTION Alaska, Alabama, Arizona, California, Iowa, Massachusetts, Michigan, Minnesota, Oregon, Nebraska, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Virginia, Washington state, Wisconsin, Canada, Chile, Colombia.
QUANTITY 77 units were distributed.
REASON The spring on the connector to the contra-angle handpiece may fracture and come loose.

PRODUCT Accurus 200PS Phacoemusification System, Catalog #8065740742, a phacoemulsification system used for opthalmic surgery featuring phacoemulsification, irrigation and aspiration capability, anterior vitrectomy, and diathermy functions
CODE SERIAL NUMBERS:
9901725601X, 9902087501X, 9901446301X, 9901725501X, 9901890101X, 9901718101X, 0001038201X, 0001038101X, 0001065601X, 9901462801X, 9901725401X, 9901463001X, 9901463101X, 9901463201X, 9901467201X, 9901707301X, 9901707401X, 9901462901X, 9901717901X, 0001005201X,
9901442401X, 9901467001X, 9901718001X, 9902003301X, 0001005101X, 0001135901X, 9901446401X, 9901446501X, 9901446601X, 9901466901X, 9901467101X, 0001005401X, 0001005301X, 9901462701X, 0001136001X, 9801357001X.
MANUFACTURER Alcon Laboratories, Inc., Irvine, California.
RECALLED BY Alcon Laboratories Inc., also known as Alcon Research LTD, Fort Worth Texas, (responsible firm)
DISTRIBUTION Florida, Maine, New Mexico, Virginia, Vermont, Australia, Germany, Italy, France.
QUANTITY 33 units were distributed.
REASON The low pressure air output (AVGFI) module used with the Alcon Accurus 200PS may unexpectedly drop to a low setting, resulting in low irrigation or infusion pressure during surgery, while vacuum remains active.

PRODUCT Dexter-ZII Blood Glucose Meter, intended for use in self-monitoring of blood glucose by persons with diabetes:a) Model 3958K2; b) Model 3958N2; c) Model 3969N2.
CODE Serial Numbers:
4000114, 4000162, 4000197, 4000330, 4001008, 4001047, 4001072, 4001118, 4001157, 4001178, 4001185, 4001191, 4001199, 4001200, 4001201, 4001215, 4001409, 4001514, 4001833, 4002475, 4002487, 4002569, 4002578, 4003218, 4003303, 4003329, 4003367, 4003443, 4003523, 4004102,
4004110, 4004112, 4004116, 4004129, 4004139, 4004158, 4004264, 4004273, 4004274, 4004278, 4004280, 4004283, 4004284, 4004298, 4004301,
4004303, 4004308, 4004500, 4004502, 4004505, 4004506, 4004511, 4004517, 4004518, 4004521, 4004526, 4004530, 4005010, 4005011, 4005050,
4005068, 4005322, 4005329, 4005359.
MANUFACTURER Bayer Corporation, Business Group Diagnostics, Mishawaka, Indiana.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Japan.
QUANTITY 64 units were distributed.
REASON The systems begin to count down prior to the inoculation of the reagent sensor.

WEEK ENDING JUNE 23

PRODUCT Peripherally Inserted Central Venous Catheter Trays containing Clinipad Cliniguard Protective Dressing Prep.
CODE Catalog number C-PICS-301. Lot F804662
Catalog number C-PICS-301-CHOP-103097. Lot F790253.
Catalog number C-PICS-301J. Lots F833591, 952989, 955791, 950762, 952988, 959369, 950763, 824639, F794489, F796661, F801539, F806269, F811737, F817595, F809235, F822207, F826239, F834114, F839371, F838672, F840052 and F838672X.
Catalog number C-PICS-301J-SACRED-HEART-062591-PKG. Lots F771187 and F791507.
Catalog number C-PICS-301J-UTAH-070992. Lots 947003, 947002, 951258, 951257, 956120, 956121 and 956892.
Catalog number C-PICS-401. Lots 956894 and 960721.
Catalog number C-PICS-401-CHOP-103097. Lots F794621, F793680, F801365, F02215 and F806310.
Catalog number C-PICS-401J. Lots 949398, 955792, 949401, 956606, 956607, 956608, 949400, 960481, 948053, 955793, 955795, 932069X, 955794, 949399, 960482, F789187, F796784, F797974, F801540, F806623, F806270, F810223, F816240, F819630, F822721, F824841, F826240, F833302, F791829, F810408 and F828140.
Catalog number C-PICS-401J-JGH-121698. Lots F794145, F809021 and F811276.
Catalog number C-PICS-401J-SACRED-HEART-062591-PKG. Lots F784415, F801146, F800823, F818856 and F833973.
Catalog number C-PICS-401J-UTAH-070992. Lots 951914, 945532, 949403, 951915, 932792X, 956896, 957631, 956895, 956123, 956122 and 945530
Catalog number C-PICS-401J-X. Lot F811185.
Catalog number C-PICS-501. Lots F794146, F810409, and F828141.
Catalog number C-PICS-501-ANDREWS-021191. Lots F804082 and F830783.
Catalog number C-PICS-501E-MCCREADY-041994. Lot F797212.
Catalog number C-PICS-501J. Lots F791623, F827945, 959620, 957447, 945802, 959618, 950481, 959621, 950482, F789188, F790483, F794490, F796662, F796785, F799725, F801541, F802192, F806271, F810986, F817596, F819631, F820587, F821289, F826998, F822208, F834115, F839372, F840053, 957446, F810410, F828142, and 945801.
Catalog number C-PICS-501J-ST-MARK-060391. Lot F792267.
Catalog number C-PICS-501J-UTAH-070992. Lots F833885, F833992, F832109, F800450, F803795, F81222, F801538, F834317, and F805245.
Catalog number C-PICSY-301J-RP-011195. Lots 947305 and954515
Catalog number C-PICSY-401J. Lots 952430, 952431, 955796, 956899, 954222, 954223, 955797, 963886, 958901, and 956901.
Catalog number PICS-301-MPIS. Lots 956622, 954243, 954241, 958626, 958628, 958627, 943780, 951932, 951933, 956621, 954242, 957849, 956623, 954244X, 957850, 951930X, 943781, 957851, 960528, 957848, 960529, 958625, 954244 and 932824
Catalog number PICS-301-MPIS-A. Lots 952696, 95049,7 950498, 958629, 940831X, 942163, 942164, 958630, 960216, 960215, 958631 and 936028.
Catalog number PICS-301-MPIS-CMC-072899. Lot F794588.
Catalog number PICS-301-MPIS-NT. Lots F811680, F807565, F823367, F834675, F823631, F788865, and F815245.
Catalog number PICS-301-MPIS-WOC. Lots 953050, 953051, 954930, 959895, 954931, 947316, 944002, 947314, 945820 and 959897
Catalog number PICS-301-MPIS-WOC-NT. Lots F796253, F808401, F793351, F797779, F803200, F808243, F814403, F804945 and F831196
Catalog number PICS-401-MPIS. Lots 951935, 949429, 953673, 953682, 957860, 959652, 951938, 953674, 953676, 956955, 957857, 959654, 959658, 961686, 951944, 956962, 957853, 959655, 959659, 942533X, 953679, 956961, 953680, 951936, 951937, 951947, 953678, 953677, 956960, 956959, 957854, 956958, 959656, 951939, 951940, 953676X, 956956, 959657, 956954, 956957, 951943, 957855, 957856, 951944X, 957852, 951942, 951941, 951945, 953681, 957859, 957858, 953671, 961692, 961689, 953672, 951946, 953675, F796338, 959653, 961690, F790506, F793794, F797481, F794509, F798001, F799742, F801563, F806294, F816278, F809247, F819660, F820610, F822748, F824879, F831102, F840130, F809671 and F828982.
Catalog number PICS-401-MPIS-A. Lots F818826, F832821 and F786275
Catalog number PICS-401-MPIS-A-NT. Lot F784799.
Catalog number PICS-401-MPIS-NT. Lots 953369, 955847, 965127, 960219, 958632, 960217, 958633, 960218, 963916, 962112, 966520, 962111, 953368, 963917, 956427, 953367, 948897, 965128, 955846, 955845, 956428, 966521, F819556 and 948896.
Catalog number PICS-401-MPIS-WOC. Lots F803427, F821904, F841997, 958105, 952170, 953684, 961442, 948125X, 959388, 952169, 948125, 953683, 963918, 961441, 958106, 952169X, 959387, F790507, F822529, F824880 and F828983.
Catalog number PICS-401-MPIS-WOC-NT. Lots 953052, 962113, 958108, 957467, 958107, 957468, 956151, 950097, 950096, 962114, 956152, 953053, 959898, 959899 and 957469.
Catalog number PICS-501-ANDREWS-021191. Lot F817156.
Catalog number PICS-501-MNP-ABMH-071895. Lots F786365, F822816, and F822816X.
Catalog number PICS-501-MPIS. Lots F799511, F799557, F804730, 953083, 953063X, 956432, 956435, 956430, 950830, 955197, 955201, 950826, 950819, 959394, 959395, 959401, 953067, 953062, 953059, 955186, 955177, 956446, 959406, 950832, 953071, 953077, 955172, 956441, 957879, 959391, 957886, 959402, 956447X, 955194, 956437, 961449, 959412, 956436, 956440, 956438, 956442, 956448, 957864, 959396, 959408, 953058, 961460, 953075, 953055, 953068, 953073, 959399, 956445, 963065, 963068, 950818, 956429, 961453, 948931X, 948926X, 950806, 953081, 959409, 950822, 950825, 950831, 953082, 957869, 957870, 959407, 959398, 950833, 959393, 959400, 961462, 961465, 953061, 955202, 955195, 961464, 961459, 953079, 956433, 955184, 955176, 961446, 961444, 961445, 959404, 956447, 955178, 955188, 950824, 955171, 953078, 953063, 956452, 956449, 963083, 963072, 957876, 955196, 957874, 957886, 953084, 953072, 956451, 950817, 953056, 953060, 961452, 961451, 957862, 959397, 961455, 961461, 961463, 953085, 963086, 956450, 955179, 956431, 956444, 957863, 957884, 957880, 957882, 953066, 963084, 950821, 953073X, 963070, 955175, 963078, 955182, 950804, 957875, 955172X, F790508, F794510, F799743, F807506, F809248, F819687, F831103, F836367, F840131, 961454, 961456, 953080, F794069, F809672, F808803, F828984, 950811, 950808, 959410, 957861X, 961448, 957877, 956431X, 955190, 957867, 963067, 950816X, 956453, 953080X and 953081X.
Catalog number PICS-501-MPIS-A. Lots 957198, 938781, 950836, 957199, 955849, 955848, 959167, 950835 and 950814.
Catalog number PICS-501-MPIS-MSH-091098. Lot F0802114.
Catalog number PICS-501-MPIS-NT. Lots 950851, 953089, 953093, 953097, 958645, 953094, 953099, 956966, 956963, 956974, 96972, 959672, 959662, 961103, 962121, 961110, 95494B, 958637, 961106, 953098, 954933, 954934, 954935, 959663, 961111, 954946, 956968, 959670, 961105, 961108X, 961102, 958641, 958644, 959668, 959666, 958634, 956970, 958638, 958640, 962115, 959671, 954942, 961108, 959669, 954947, 956973, 953086, 953088, 950838, 950839, 950846, 950848, 950849, 956969, 956975, 956976, 954939, 956965, 956967, 962123, 962118, 962122, 962125, 954938, 961104, 950852, 959661,
961100, 954944, 958635, 961107, 963642, 954940, 961101, 958639, 953087, 959665, 9533096, 954945, 962117, 962120, 963638, 953091, 961109, 958642, 953095, 953100, 954937, F789125, 953090, 950845, 956977, 953092, 954936, 958643, 956964, 959667, 956971, F796337, 950847, 954943, 948603, F819555, 954950, 961112, 954941, 954932, 958636, 953099X, 954949, 959670X, 959664, 959661X, 962116 and 950844.
Catalog number PICS-501-NT-MCLELLAN. Lot F793031.
Catalog number PICS-501-MPIS-NT-PGHC-122396. Lots F832007 and F827711.
Catalog number PICS-501-MPIS-ON. Lot F801842.
Catalog number PICS-501-MPIS-WOC. Lots 959674, 951641, 951642, 951644, 954248, 954245, 954246, 958111, 959673, 958112, 948623, 951645, 959676, 954247, 951639, 951643, 958110, 959675, 948617, 954249, 951640, 948622, 929837X, 933160X, 958109, F790509, F788527, F815515, F822749, F834890, F796429, F809673 and F828985.
Catalog number PICS-501-MPIS-WOC-NT. Lots 957887, 956625, 952439, 952441, 954951, 957889, 952442, 952440, 948625, 960221, 955852, 955851, 960220, 955853, 956626, 957888, 956624, 960220X, F796693, F820611, F840132 and 960222.
Catalog number PICS-ST-VINCENT-040593. Lots F828118 and F829634.
Catalog number PICS-401-MPIS. Lots 946700, 950499, 957890, 957891, 959900, 963332 and 959901.
Catalog number PICSY-501-MPIS. Lots 950502, 951948, 954955, 951949, 954250, 956978, 956979, 954251, 954956, 950501 and 958646.
These products are packaged with Clinipad CLINIGUARD, Protective, Dressing, Prep, 1, Prep, Pad-Clinipad, Reorder Code 8133S-B, HK8133S. Lot number 914358 [Contains: Isopropyl, Alcohol, 79%, Butyl, Mono, Ester, Dimetyl, Phthalate].
MANUFACTURER Cook Inc., Bloomington, Indiana (tray); Venetec International, Inc., San Diego, California (stalock anchoring device)
RECALLED BY Cook, Inc., Bloomington, Indiana
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 21,520 Cook kits were distributed.
REASON Kits/trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Osteonics Scorpio Posteriorly Stabilized Total Knee:
a) Catalog Number: 71-5105L; b) Catalog Number: 71-5105R
c) Catalog Number: 71-5107L; d) Catalog Number: 71-5107R
e) Catalog Number: 71-5109L; f) Catalog Number: 71-5109R
g) Catalog Number: 71-5111L; h) Catalog Number: 71-5111R
i) Catalog Number: 71-5113L.
CODE a) Case Codes: K00A257, K00A87, K00A88, K99W347, K99W348, K99W349, K99W459, K99W460
b) Case Codes: K00A258, K00A89, K00A90, K99W461
c) Case Codes: K00A91, K00A92, K00A93, K99W462, K99W463, K99W464,K99W89
d) Case Codes: K00A262, K00A94, K00A95, K00A96, K00A97, K99S246, K99W465, K99W467, K99W468, K99W469, K99W607
e) Case Codes: K00A100, K00A500, K00A98, K00A99, K99W472, K99W471, K99W783
f) Case Codes: K00A101, K00A102, K00A103, K00A265, K99W188, K99W474, K99W475, K99W477, K99W610
g) Case Codes: K00A429, K99W193, K99W749, K99W750, K99W751
h) Case Codes: K99W196, K99W197, K99W753, K99W754
i) Case Code: K99W198.
MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY 10 units were distributed.
REASON Product labeling has additional line stating "All Polyethylene" below the product name.

PRODUCT Amplified Mycobacterium Tuberculosis, in-vitro diagnostic test kit:
a) Part No. 301001, Lot Nos. 909399, 911170, 911172, Exp. Date 08/02/00;
INTERNATIONAL KITS:
b) Part No. 301001E, Lot Nos. 909400, 909410, 912246, Exp. Date 08/02/00;
c) Part No. 301001F, Lot Nos. 909352, 912294, Exp. Date 08/02/00;
d) Part No. 301002J, Lot Nos. 909135 Exp. Date 02/23/00, 909254 Exp. Date 03/18/00, 910352 Exp. Date 04/11/00; Part No. 301011J, Lot Nos. 909136 Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp. Date 04/11/00;
CODE Domestic: a) Lot Nos. 909399, 911170, 911172, Exp. Date 08/02/00;
INTERNATIONAL KITS: b) Lot Nos. 909400, 909410, 912246, Exp. Date 08/02/00; c) Lot Nos. 909352, 912294, Exp. Date 08/02/00; d) Lot Nos. 909135 Exp. Date 02/23/00, 909254 Exp. Date 03/18/00, 910352 Exp. Date 04/11/00 (Part #301002J); Lot Nos. 909136 Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp. Date 04/11/00 (Part No. 301011J).
MANUFACTURER Gen-Probe, Inc., San Diego, California.
DISTRIBUTION Nationwide, Puerto Rico, Switzerland, Canada.
QUANTITY 1,414 kits were distributed.
REASON The above reagent experienced a reduced shelf life after being reconstituted. The reduced shelf life may result in inadequate amplification of some specimens during a test run. Inadequate amplification may produce false negative results.

PRODUCT DeVilbiss Portable Ultrasonic Nebulizer DC Power Cord.
CODE Catalog #5500D-616.
MANUFACTURER Sunrise Medical HHG, Inc., Somerset, Pennsylvania.
DISTRIBUTION Nationwide and Canada.
QUANTITY 370 units.
REASON The wrong DC power cord was supplied with the nebulizer.

WEEK ENDING JUNE 30

PRODUCT MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Lens: a) Model No. U940A, MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular; b) Model No. U940S, MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular Lens.
CODE All Lot Numbers manufactured on or before 3/24/2000.
MANUFACTURER Ciba Vision Corporation, Duluth, Georgia.
QUANTITY 263,000 units were distributed.
REASON Implantation of this lens may cause postoperative inflammation.

PRODUCT T-9 Scoop Transtracheal Procedure Tray.
CODE Lot Numbers: 0339, 1409, 2749.
MANUFACTURER Transtracheal Systems, Englewood, Colorado.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 643 trays.
REASON Trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT SYSMEX CA-1000 and SYSMEX CA-5000 Automated Coagulation Analyzer, used to the clotting times of heparinized patients to adjust their heparin treatment.
CODE All serial numbers.
MANUFACTURER Sysmex Corp., Kobe, Japan
RECALLED BY Sysmex Corporation of America, Long Grove, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 1,405 CA-1000 analyzers and 132 CA-5000 analyzers were distributed.
REASON Incorrect aPTT (activated partial thromboplastin time) analysis of patient Samples which contain elevated levels of fibrinogen or fibrinogen-related products which are not measured by aPTT (fibrinogen monomer) could occur.

PRODUCT Walkmed Administration Sets for WalkMed Infusion Pumps:
a) Catalog #PS-400/300; b) Catalog #EFV-101S; c) Catalog #EFV-101B; d) Catalog #FPS-560.
CODE Lot Numbers: a) Lot 9I112, 9I113, 9J115, 9K103; b) D991020-B; c) D991027-A; d) D991202-A.
MANUFACTURER McKinley Medical, LLLP, Wheat Ridge, Colorado.
DISTRIBUTION Nationwide and international.
QUANTITY 41,720 sets were distributed.
REASON Defective plastic elbow connector could allow leak or air introduction.

PRODUCT Curity Spinal Anesthesia Tray; Safe Tap Spinal Anesthesia Tray; Spinal Anesthesia; Saddle Block and Customer Special Spinal Tray.
CODE Note: This recall only applies to alpha numeric lot numbers beginning with "FE83", "HE83", "JE83" and "GE83"; numerical lot numbers beginning with "0", "4", "5" and "9".
Part # Description
470 CURITY Spinal Anesthesia Tray
4716 CURITY Spinal Anesthesia Tray
4720 CURITY Spinal Anesthesia Tray
4722 CURITY Spinal Anesthesia Tray
4724 CURITY Spinal Anesthesia Tray
4727 CURITY Spinal Anesthesia Tray
4730 CURITY Spinal Anesthesia Tray
4731 CURITY Spinal Anesthesia Tray
4747 Safe Tap Spinal Anesthesia Tray
4748 Safe Tap Spinal Anesthesia Tray
4749 Safe Tap Spinal Anesthesia Tray
4760 CURITY Spinal Anesthesia Tray/Saddle Block
4761 CURITY Spinal Anesthesia Tray
4762 CURITY Spinal Anesthesia Tray
4763 CURITY Spinal Anesthesia Tray/Saddle Block
4764 CURITY Spinal Anesthesia Tray/Saddle Block
4765 CURITY Spinal Anesthesia Tray
4766 CURITY Spinal Anesthesia Tray
4767 CURITY Spinal Anesthesia Tray/Saddle Block
4768 CURITY Spinal Anesthesia Tray
4769 CURITY Spinal Anesthesia Tray
4770 CURITY Spinal Anesthesia Tray
4787 CURITY Spinal Anesthesia Tray/Saddle Block
4795 CURITY Spinal Anesthesia Tray/Saddle Block
4815 CURITY Spinal Anesthesia Tray
4920 CURITY Spinal Anesthesia Tray
5171 Continuous Epidural Anesthesia Tray
10569 Customer Special: Spinal Tray
10584 Customer Special: Spinal Tray
10590 Customer Special: Spinal Tray
10614 Customer Special: Spinal Tray
10616 Customer Special: Spinal Tray
10617 Customer Special: Spinal Tray
10618 Customer Special: Spinal Tray
10641 Customer Special: Spinal Tray
10702 Customer Special: Spinal Tray
10705 Customer Special: Spinal Tray
10708 Customer Special: Spinal Tray
472867 Customer Special: Spinal Tray
476827 Customer Special: Spinal Tray.
MANUFACTURER The Kendall Company LP, Mansfield, Massachusetts.
DISTRIBUTION Nationwide, Japan, Panama, Bahamas, Saudi Arabia.
QUANTITY Approximately 14,570 cases.
REASON Spinal anesthesia trays contain recalled Epinephrine Injection USP, 1 ml ampule.

PRODUCT Vasoview Dissection/Vessel Harvesting System: a) VasoView, Part #09331; b) Vasoview Uniport, Part #11344; c) Vasoview Uniport Plus, Part #11346. The VasoView Uniport dissection cannula has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting surgery for arterial bypass.
CODE All codes.
MANUFACTURER Guidant Corporation, Menlo Park, California.
DISTRIBUTION Nationwide and international.
QUANTITY 5,730 units were distributed.
REASON Sterility may be compromised as evidenced by a loss of package integrity.

PRODUCT Version 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device.
CODE All versions of the software used with CDT LAN Monitoring Systems.
MANUFACTURER GE Marquette Medical Systems, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Nationwide and international.
QUANTITY 2,254 units were distributed.
REASON Due to a software defect, there could be alarm failure.

PRODUCT Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove suprious image slices from a scan.
CODE Fixer Software Utility Version 3.0
MANUFACTURER Radionics, Inc., Burlington, Massachusetts.
DISTRIBUTION Nationwide and international.
QUANTITY 33 installed bases.
REASON Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session.

PRODUCT Sarita and Sarita 160 Patient Lift, Non-AC Powered Lift/Transfer System used to transfer patients/residents between beds, chairs and toilets: a) Model KKA0400; b) KKA0420-16; c) KKA0401; d) KKB3000-11US; e) KKB3020-16US.
CODE All serial numbers prior to 4899 834795-011 Model KKB3000-11US - Sarita; Model KKB3020-16US - Sarita 160.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 967 units were distributed.
REASON Premature cracking of foot support platform of the lift.

PRODUCT Maxilift Patient Lift, Non-AC powered, used to move patients in a nursing home situation.
CODE All serial numbers preceding week 1/95, with serial number prefixes preceding US0195, SE0195, GB0195, and include serial numbers beginning with 93MM, 93ME, 94MM and 94ME.
Model 211026, Maxilift Manual Chassis with Scale
Model 212624, Maxilift Manual Chassis - Beige
Model 210024-06, Maxi Scale Std - Beige
Model 212000-06, Maxi Pillar Beige
Model KMB0810-06US, Maxilift Combi
Model KMB0830-06US, Maxilift Combi with Scale
Model KMB2351, Maxilift Electric with Scale
Model MA0500, Maxi Pillar
Model MA0510, Maxi Mast for Electric Chassis
Model MB0500, Maxilift Beige
Model MB0510, Maxilift with Battery Powered Chassis
Model MB0600, Maxilift with Scale - Beige
Model MB0610, Maxilift Battery Powered with Scale.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,017 units were distributed.
REASON Spring (roll) pin subject to shear in Maxilifts greater than 5 years old.

PRODUCT Maximove Patient Lift, Non-AC powered, used to move patients in a nursing home situation: Models KRA0300, MA0510, KMA1004, KMB0810-06, KMB0830-06, KMB4500-12US, KMB6950-12US, KMB6970-12US, KMB6980-12US.
CODE Maximove models KRA0300 (mast Model), KMB4500-12US, KMB6950-12US, KMB6970-12US, KMB6980-12US, serial numbers GB 2097 784578 001 through GB 0899 819426 006; weeks 20/97 through 08/99
Model KMB4500-12US - Maximove with powered V chassis
Model KMB6950-12US - Maximove with powered parallel chassis & scale
Model KMB6970-12US - Maximove with powered parallel chassis
Model KMB6980-12US - Maximove with powered V chassis & scale
Maximove Combi models KRA0300 (Mast model) and KMA1004, serial numbers start with GB or SE; weeks 03/96 through 05/99
Model KMA1004 - Maximove Combi Lift Arm Assembly
Maxilift Combi models MA0510 (Mast Model), KMB0810-06, KMB0830-06, serial numbers GB 0596 770428 003 through GB 3496 773176 010; weeks 05/96 through 34/96
Model KMB0810-06US, Maxilift Combi
Model KMB0830-06US, Maxilift Combi with Scale.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,465 units were distributed.
REASON Over depression of the locking spring pin results in the lift arm not locking.

PRODUCT Marisa Patient Lift, Non-AC Powered, used to move weak or highly dependent patients in a nursing home situation: a) Model KGB2000-US, Marisa Complete with Jib, but no Scale; b) Model KGB2100-US, Marisa Complete with Jib and with Scale ; c) Model KGA0200.
CODE All serial numbers below GB 3298 807390 002.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,331 lifts were distributed.
REASON Jib assembly plunger may not fully engage in the carriage receptacle.

PRODUCT Vitros Cardiology Controls (human serum), for in-vitro diagnostic use only, Catalog #865 0939.
CODE Lot number 50.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.
DISTRIBUTION California, District of Columbia, Illinois, Indiana, Montana, Nevada, Ohio, New York, South Carolina, Texas, Virginia, Wisconsin, Australia, Brazil, Canada, Singapore, England and France.
QUANTITY 338 packs were distributed.
REASON Cardiology controls gave low values approximately 2 standard deviations below target values.

PRODUCT Cemented Hip Stem, Catalog #6098-0940.
CODE Case Code: 46364801
Serial Numbers: 20458S, 20459D, 20461S, 20462S, 20463S, and 38086P.
MANUFACTURER Stryker Howmedica Osteonics, Allendale, New Jersey.
DISTRIBUTION Illinois, Minnesota, Oklahoma and Canada.
QUANTITY 5 units were distributed.
REASON Mislabeling - The device is labeled having a 127 degree neck angle when in fact the hip stem actually have a 132 degree neck angle.

PRODUCT IMx hCG Calibrators, for in Vitro Diagnostic use. The Imx hCG Calibrators are for the calibration of the Imx Anallyzer when used for the quantitative/qualitative determination of human chorionic gonadotropin (hCG) for the early detection of pregnancy.
CODE List #3A63-01, Lot #55552Q100 EXP 5/13/00.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
DISTRIBUTION Nationwide, Australia, Canada, Germany, Italy, Japan, and Mexico.
QUANTITY 234 kits were distributed.
REASON The IMx hCG Calibrator lot 55552Q100 rates have decreased over time which may result in elevated control values.

PRODUCT Pentalumen Thermodilution Catheter, Heparin Coated, Flow-Directed Thermodilution Pulmonary Artery Catheder, Rx device for rapid and accurate measurement of hemodynamic pressure and determination of cardiac output using a cardiac output computer.
CODE List #412320401, Lot #59-249-SN.
MANUFACTURER Abbott Laboratories, Salt Lake City,UT.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Nationwide, Canada, Chile.
QUANTITY 960 catheters were distributed.
REASON One or more of the lumens in the catheter may be occluded.

PRODUCT Genesis II and Profix Porous Femoral Components, sterile product, packaged one per container for use by an orthopaedic surgeon:
Genesis II Femoral Components:
Description      Part Number     Lot
Sz 3 LT             71420036         00111302
Sz 4 LT             71420038         91106643
Sz 5 LT             71420040         00111462
Sz 5 LT             71420040         00111463
Sz 5 LT             71420040         00304339
Sz 5 LT             71420040         00304340
Sz 6 LT             71420042         91103882
Sz 6 LT             71420042         91103883
Sz 6 LT             71420042         91107062
Sz 6 LT             71420042         91107063
Sz 6 LT             71420042         91107064
Sz 6 LT             71420042         00101454
Sz 6 LT             71420042         00101457
Sz 7 LT             71420044         00206821
Sz 7 LT             71420044         00206822
Sz 4 RT             71420054         91201372
Sz 4 RT             71420054         91201373
Sz 4 RT             71420054         91201371
Sz 4 RT             71420054         91204594
Sz 4 RT             71420054         00101463
Sz 4 RT             71420054         00101464
Sz 4 RT             71420054         00111306
Sz 4 RT             71420054         00111307
Sz 4 RT             71420054         00111308
Sz 5 RT             71420056         91107068
Sz 5 RT             71420056         91107069
Sz 5 RT             71420056         91107070
Sz 5 RT             71420056         91106158
Sz 5 RT             71420056         90016159
Sz 5 RT             71420056         91106160
Sz 5 RT             71420056         91107067
Sz 5 RT             71420056         00111304
Sz 5 RT             71420056         00111304A
Sz 5 RT             71420056         00404566
Sz 5 RT             71420056         00404567
Sz 5 RT             71420056         00404563
Sz 5 RT             71420056         00404564
Sz 5 RT            71420056         00404565
Sz 7 RT             71420060         91204591
Sz 7 RT             71420060         91204592
Sz 7 RT             71420060         00206823
Sz 7 RT             71420060         00206824
Sz 7 RT             71420060         00406018
Sz 7 RT             71420060         00406017
Sz 7 RT             71420060         00103496
Profix Femoral Components:
Description     Part Number     Lot
Sz 3 RT             71502130         00105665
Sz 4 RT             71502140         91100703
Sz 4 RT             71502150         91100704
Sz 4 RT             71502140         91107043
Sz 4 RT             71502150         91107044
Sz 4 RT             71502140         91107045
Sz 4 RT             71502150         91203073
Sz 5 RT             71502150         91101207
Sz 5 RT             71502150         91106635
Sz 5 RT             71502150         91106636
Sz 5 RT             71502150         91106146
Sz 5 RT             71502150         91106147
Sz 5 RT             71502150         91106634
Sz 5 RT             71502150         91107801
Sz 5 RT             71502150         91107802
Sz 5 RT             71502150         91107724
Sz 5 RT             71502150         91107725
Sz 5 RT             71502150         91107803
Sz 5 RT             71502150         91200417
Sz 5 RT             71502150         91200418
Sz 5 RT             71502150         91100419
Sz 5 RT             71502150         91200420
Sz 5 RT             71502150         92100416
Sz 6 RT             71502160         91101209
Sz 6 RT             71502160         91107805
Sz 6 RT             71502160         91107806
Sz 6 RT             71502160         91100706
Sz 6 RT             71502160         00209183
Sz 6 RT             71502160         00209184
Sz 6 RT             71502160         00301458
Sz 6 RT             71502160         00301457
Sz 6 RT             71502160         00301456
Sz 6 RT             71502160         00305645
Sz 2 LT             71502220         00405819
Sz 2 LT             71502220         91203766
Sz 2 LT             71502220         91204891
Sz 3 LT             71502230         91106628
Sz 3 LT             71500230         91106629
Sz 3 LT             71502230         91106630
Sz 3 LT             71500230         91106149
Sz 3 LT             71502230         91106150
Sz 3 LT             71500230         00109524
Sz 4 LT             71590001         91203525
Sz 4 LT             71590001         91203526
Sz 4 LT             71502240         91101931
Sz 4 LT             71502240         91101932
Sz 4 LT             71502240         91101933
Sz 4 LT             71502240         00104672
Sz 4 LT             71502240         00109525
Sz 4 LT             71502240         00301453
Sz 4 LT             71502240         00301454
Sz 4 LT             71502240         00310670
Sz 5 LT             71502250         91102580
Sz 5 LT             71502250         91102582
Sz 5 LT             71502250         91109920
Sz 5 LT             71502250         91109921
Sz 5 LT             71502250         91110383
Sz 5 LT             71502250         91204253
Sz 5 LT             71502250         91204254
Sz 5 LT             71502250         00109527
Sz 5 LT             71502250         00109528
Sz 5 LT             71502250         00111459
Sz 5 LT             71502250         00111461
Sz 5 LT             71502250         00200116
Sz 5 LT             71502250         00200337
Sz 5 LT             71502250         00200338
Sz 5 LT             71502250         00200339
Sz 6 LT             71502260         91107049
Sz 6 LT             71502260         91107050
Sz 6 LT             71502260         91107051
Sz 6 LT             71502260         00104674
Sz 6 LT             71502260         91108859
Sz 7 LT             71502270         91106148
Sz 7 LT             71502270         91200414
Sz 7 LT             71502270         00111298.
MANUFACTURER Smith and Nephew, Inc., Orthopaedic Division, Memphis, Tennessee.
DISTRIBUTION Nationwide and international.
QUANTITY 945 units were distributed.
REASON The bead sintering process temperature was insufficient for proper bead/substrate adhesion.

PRODUCT FreshLook Toric Soft Hydrophilic Contact Lenses for Astigmatism.
CODE Lot numbers: 101297 EXP 2003-01, 101296, EXP 2003-01.
MANUFACTURER Wesley Jessen Corporation, Des Plaines, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 564 single blister trials and 246 6-packs were distributed.
REASON Mislabeled for corrective power, cylinder and axis.

PRODUCT Cordis Smart Nitinol Stent Transhepatic Biliary System.
CODE
Catalog number 1440BB, Lot number X0200019;
Catalog number 1420BB, Lot number 40200246.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Tennessee, West Virginia, California, Louisiana, and Florida.
QUANTITY 12 units were distributed.
REASON Mislabeled guidewire size and mislabeled indication for use.

PRODUCT Cardiology Controls (human serum), for in vitro diagnostic use only.
CODE Lot #53 EXP 12/99.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.
DISTRIBUTION Alaska, California, Delaware, Indiana, Kansas, Kentucky, New York, Ohio, Oklahoma, Pennsylvania, Wisconsin, Canada, Belgium, and Germany.
QUANTITY 33 packs were distributed.
REASON Cardiology Controls gave low values approximately 2 standard deviations below target.

PRODUCT Lactate Membrane Kit Stat Profile M Series, for use with the Stat Profile M Analyzer. The Stat M. Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, and BUN in serum, plasma, and whole blood to evaluate the acid-base status of patients suspected of having lactic acidosis.
CODE Lot numbers: 901129 and 801129.
MANUFACTURER Nova Biomedical Corporation, Waltham, Massachusetts.
DISTRIBUTION Arizona, Massachusetts, Florida, Wisconsin and Germany.
QUANTITY 41 kits (6 membranes/kit) were distributed.
REASON Extended expiration date.